April 1 Quick Takes: Gedeon gets Europe rights to Myovant’s uterine fibroid therapy following MAA submission; plus Orion-Bayer, BMS-bluebird, Mesoblast and more
Myovant licenses relugolix rights to Gideon for $40M
Myovant Sciences GmbH (NYSE:MYOV) licensed rights of relugolix combination tablets to Gedeon Richter plc (Budapest:RICHTER) in Europe, Russia, Latin America, Australia and New Zealand. Myovant, which retains U.S. rights, will receive $40 million up front and is eligible to receive up to $40 million in regulatory milestones and $107.5 million in sales milestones, plus tiered royalties. In March, Myovant submitted an MAA to EMA for relugolix to treat moderate to severe symptoms associated with uterine fibroids; the company plans to submit an NDA to FDA for relugolix monotherapy this quarter.
EU approval for Orion, Bayer prostate cancer therapy
The European Commission approved Nubeqa darolutamide from Orion Corp. (HSE:ORNAV; HSE:ORNBV) and Bayer AG (Xetra:BAYN) to treat non-metastatic castration-resistant prostate cancer. FDA approved the oral androgen receptor inhibitor in July (see “Prostate Cancer Disrupted”)...